Module

Clinical Development

The Clinical Development program at Paul Janssen Futurelab Leiden provides “learning-by-doing” training to ambitious postgraduate biomedical researchers who wish to further their career and increase their knowledge on the development of novel medical interventions. The program focuses on several important aspects associated with the development medicinal products, medical devices, and medical nutrition products. The Clinical Development program consists of three sequential courses:

Clinical Development Online

In this five-week online Futurelab course, you are introduced to the question-based method of clinical development. This approach, which is based on the so-called Real Options Theory, facilitates the rational and efficient design of a pathway for developing novel medical interventions. Although this approach is used only rarely in the biomedical sector, it is used commonly in many other industries. During this course, you will learn how to apply this approach using the Futurelab tool. You will also learn to formulate key questions to be answered during the development process and to estimate both the associated costs and the likelihood of answering these key questions.
It is important to note that each course must be completed before the next course can be taken. Moreover, although course participants are encouraged to pursue all three courses in the program, it is possible to take this online course as a stand-alone (i.e., terminal) course.

A multifaceted online course

In this online course, a variety of exercises will help you master the Futurelab tool and use question-based development to approach real-world scenarios based on real-world case studies. In addition, the online course uses a wide variety of teaching methods, including animations, tutorials, scientific articles, interviews with industry experts and authorities, Futurelab talks, self-assessment tools, quizzes, assignments, online discussions with fellow course participants, and feedback from Futurelab experts.

Online, for your convenience

Each week of the course starts by watching an episode of the Futurelab series QUESTIONS!, in which physician-researcher Claire, who recently obtained her Ph.D., starts in her new job at a biotech company. Being responsible for the development of a novel compound, Claire quickly discovers the advantages of using the question-based approach compared to the more commonly used Net Present Value (NPV) method.

Online exam

Your understanding of the course material will be assessed by an online exam. You will need access to a laptop with webcam, a stable internet connection, a clean desk, and a private room. Participants will be monitored by a professional invigilator via webcam during the exam. After passing the exam, you will obtain a Paul Janssen Futurelab certificate and will be eligible to apply for the on-campus course.

Study time

You will be expected to spend approximately 5 hours per week for five consecutive weeks.

Learning outcomes

Upon completing this course, you will be able to design the optimal path for developing a novel medical intervention. Specifically, you will be able to:

recognize the disadvantages of using the NPV method and the advantages of using the question-based approach;

identify the most important questions that will need to be answered during the development process;

identify the uncertainties associated with answering these questions; and

identify the costs associated with the development process and estimate the potential revenues that may arise following successful development.

The Paul Janssen Futurelab Leiden uses (amongst others) teaching case studies that are (in part) based on real-life cases. At the end of the session we reveal the results that occurred in real-life for the case. We herewith kindly request you not to reveal the content and the outcomes of the cases to others outside the course, to ensure that the learning experience for future course participants is not spoiled. As part of this policy, some course material can’t be downloaded or printed, but can be viewed from the Paul Janssen Futurelab Leiden website only.

Statement*

I have read and understand the statement above and agree not to reveal the content of the teaching case studies and the outcomes to others outside the course.

Please use the template below to provide a short summary of your proposed clinical trial

Download template Summary Proposal

A highly competitive €500,000 grant from the Dutch funding agency ZonMw is available for the best clinical trial application developed during this course for a clinical trial with a registered medicinal product to be conducted in a Dutch research institute or hospital. Paul Janssen Futurelab Leiden will review all developed clinical trial applications during this course and award the best proposal with a nomination letter that can be included in the application for the ZonMw grant.

ZonMw grant of €500,000

I would like to join the competition for the Nomination letter to obtain the ZonMw grant.

Yes, I'm joining the competition

Download template Letter of Department Head

The Paul Janssen Futurelab Leiden uses (amongst others) teaching case studies that are (in part) based on real-life cases. At the end of the session we reveal the results that occurred in real-life for the case. We herewith kindly request not to reveal the content and the outcomes of the cases to others outside the course, to ensure that the learning experience for future course participants remains intact. As part of this policy, some course material can’t be downloaded or printed, but can be viewed from the Paul Janssen Futurelab Leiden website only.

Statement*

I have read and understand the statement above and agree not to reveal the content of the teaching case studies and the outcomes to others outside the course.